Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT00227032
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed glioblastoma multiforme (or high-grade glioma that is behaving clinically and/or radiographically like glioblastoma multiforme)
* Progressed after first-line therapy (e.g., surgery, chemotherapy, or radiotherapy)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 8.5 g/dL
* ALT and AST \< 2 times upper limit of normal (ULN)
* Alkaline phosphatase \< 2 times ULN
* Bilirubin \< 1.5 mg/dL
* Creatinine \< 1.5 mg/dL OR creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No diagnosis or history of significant renal or hepatic disease
* No contraindication (e.g., mass effect, brain shift) to lumbar puncture procedure
* No active infection
* No diagnosis or history of corneal abnormalities
* No diagnosis or history of malabsorptive syndrome or other disorder affecting gastrointestinal absorption
* No history of hypersensitivity reactions to midazolam hydrochloride (CYP3A4 biomarker)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00227032
Study Brief:
Protocol Section:
NCT00227032